FDA 510(k) Applications Submitted by DADE BEHRING, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040133 |
01/21/2004 |
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K060266 |
02/01/2006 |
DIMENSION IRON CALIBRATOR |
DADE BEHRING, INC. |
| K060264 |
02/01/2006 |
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) |
DADE BEHRING, INC. |
| K061503 |
06/01/2006 |
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) |
DADE BEHRING, INC. |
| K061793 |
06/26/2006 |
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
| K052017 |
07/26/2005 |
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 |
DADE BEHRING, INC. |
| K052015 |
07/26/2005 |
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 |
DADE BEHRING, INC. |
| K032798 |
09/09/2003 |
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A |
DADE BEHRING, INC. |
| K053109 |
11/04/2005 |
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K053104 |
11/04/2005 |
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
| K033713 |
11/26/2003 |
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A |
DADE BEHRING, INC. |
| K071980 |
07/18/2007 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H |
DADE BEHRING, INC. |
| K081249 |
05/02/2008 |
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
DADE BEHRING, INC. |
| K981097 |
03/26/1998 |
STRATUS CS CKMB CALPAK |
DADE BEHRING, INC. |
| K981098 |
03/26/1998 |
STRATUS CS CARDIAC TROPONIN I TESTPAK |
DADE BEHRING, INC. |
| K981099 |
03/26/1998 |
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK |
DADE BEHRING, INC. |
| K981100 |
03/26/1998 |
STRATUS CS TROP CALPAK |
DADE BEHRING, INC. |
| K981101 |
03/26/1998 |
STRATUS CS MYO CALPAK |
DADE BEHRING, INC. |
| K981102 |
03/26/1998 |
STRATUS CS MYOGLOBIN (MYO) TESTPAK |
DADE BEHRING, INC. |
| K991181 |
04/07/1999 |
MODIFICATION OF N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
| K991157 |
04/07/1999 |
N LATEX STFR REAGENT |
DADE BEHRING, INC. |
| K991182 |
04/07/1999 |
MODIFICATION OF N/T PROTEIN CONTROL SL |
DADE BEHRING, INC. |
| K984501 |
12/18/1998 |
DADE BEHRING BFTII |
DADE BEHRING, INC. |
| K011852 |
06/12/2001 |
DIMENSION HAIC ASSAY, MODEL DF105 |
DADE BEHRING, INC. |
| K990255 |
01/27/1999 |
DIMENSION DRUG CALIBRATOR II, MODEL DC49B |
DADE BEHRING, INC. |
| K990251 |
01/27/1999 |
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 |
DADE BEHRING, INC. |
| K990554 |
02/22/1999 |
DIMENSION SPECIAL PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
| K990551 |
02/22/1999 |
IGG FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K990552 |
02/22/1999 |
IMMUNOGLOBULIN A TEST SYSTEM |
DADE BEHRING, INC. |
| K990553 |
02/22/1999 |
IGM FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K983548 |
10/09/1998 |
FERRITIN CALIBRATOR |
DADE BEHRING, INC. |
| K003209 |
10/13/2000 |
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A |
DADE BEHRING, INC. |
| K020162 |
01/17/2002 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN |
DADE BEHRING, INC. |
| K020160 |
01/17/2002 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN |
DADE BEHRING, INC. |
| K010418 |
02/12/2001 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K020822 |
03/13/2002 |
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN |
DADE BEHRING, INC. |
| K020820 |
03/13/2002 |
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME |
DADE BEHRING, INC. |
| K021037 |
04/01/2002 |
MICROSTREP PLUS PANEL WITH AMPICILLIN |
DADE BEHRING, INC. |
| K051202 |
05/11/2005 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K032706 |
09/02/2003 |
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML |
DADE BEHRING, INC. |
| K023361 |
10/07/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) |
DADE BEHRING, INC. |
| K023541 |
10/22/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) |
DADE BEHRING, INC. |
| K033940 |
12/19/2003 |
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) |
DADE BEHRING, INC. |
| K033948 |
12/19/2003 |
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) |
DADE BEHRING, INC. |
| K043545 |
12/23/2004 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) |
DADE BEHRING, INC. |
| K050043 |
01/10/2005 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN |
DADE BEHRING, INC. |
| K042687 |
09/29/2004 |
ENZYGNOST F+2 (MONOCLONAL) TEST KIT |
DADE BEHRING, INC. |
| K020692 |
03/04/2002 |
EMIT 2000 VANCOMYCIN ASSAY |
DADE BEHRING, INC. |
| K020845 |
03/15/2002 |
EMIT 2000 VANCOMYCIN CALIBRATORS |
DADE BEHRING, INC. |
| K050665 |
03/15/2005 |
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) |
DADE BEHRING, INC. |
| K010871 |
03/23/2001 |
TGL FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K001256 |
04/19/2000 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
| K021381 |
05/01/2002 |
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 |
DADE BEHRING, INC. |
| K041870 |
07/09/2004 |
N APOLIPOPROTEIN STANDARD SERUM |
DADE BEHRING, INC. |
| K022290 |
07/15/2002 |
PROTEIN S AC |
DADE BEHRING, INC. |
| K042209 |
08/16/2004 |
CONTROL PLASMA N AND CONTROL PLASMA P |
DADE BEHRING, INC. |
| K023141 |
09/20/2002 |
MODIFICATION TO STANDARD HUMAN PLASMA |
DADE BEHRING, INC. |
| K023312 |
10/03/2002 |
CONTROL PLASMA P |
DADE BEHRING, INC. |
| K023309 |
10/03/2002 |
CONTROL PLASMA N |
DADE BEHRING, INC. |
| K993310 |
10/04/1999 |
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH |
DADE BEHRING, INC. |
| K012233 |
07/16/2001 |
STRATUS CS TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K010314 |
02/02/2001 |
DIMENSION CTNI CALIBRATOR |
DADE BEHRING, INC. |
| K010313 |
02/02/2001 |
DIMENSION CTNI FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K060628 |
03/09/2006 |
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR |
DADE BEHRING, INC. |
| K020980 |
03/26/2002 |
DIMENSION TPSA CALIBRATOR, MODEL #RC459 |
DADE BEHRING, INC. |
| K031343 |
04/29/2003 |
TPSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K061839 |
06/29/2006 |
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 |
DADE BEHRING, INC. |
| K071834 |
07/03/2007 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM |
DADE BEHRING, INC. |
| K042347 |
08/30/2004 |
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD |
DADE BEHRING, INC. |
| K033487 |
11/04/2003 |
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI |
DADE BEHRING, INC. |
| K043476 |
12/16/2004 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT |
DADE BEHRING, INC. |
| K063756 |
12/19/2006 |
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K003963 |
12/22/2000 |
DIMENSION PSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K053576 |
12/22/2005 |
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
| K053577 |
12/22/2005 |
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT |
DADE BEHRING, INC. |
| K061719 |
06/19/2006 |
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 |
DADE BEHRING, INC. |
| K071247 |
05/04/2007 |
N LATEX RF KIT |
DADE BEHRING, INC. |
| K081161 |
04/24/2008 |
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST |
DADE BEHRING, INC. |
| K072717 |
09/25/2007 |
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 |
DADE BEHRING, INC. |
| K063508 |
11/20/2006 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN |
DADE BEHRING, INC. |
| K073561 |
12/19/2007 |
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR |
DADE BEHRING, INC. |
| K982591 |
07/24/1998 |
DADE TRU-LIQUID CARDIAC CONTROL |
DADE BEHRING, INC. |
| K000459 |
02/11/2000 |
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A |
DADE BEHRING, INC. |
| K000460 |
02/11/2000 |
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A |
DADE BEHRING, INC. |
| K000461 |
02/11/2000 |
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A |
DADE BEHRING, INC. |
| K000462 |
02/11/2000 |
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A |
DADE BEHRING, INC. |
| K000464 |
02/11/2000 |
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A |
DADE BEHRING, INC. |
| K000466 |
02/11/2000 |
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A |
DADE BEHRING, INC. |
| K000467 |
02/11/2000 |
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
DADE BEHRING, INC. |
| K000458 |
02/11/2000 |
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A |
DADE BEHRING, INC. |
| K050928 |
04/14/2005 |
DADE THROMBIN REAGENT |
DADE BEHRING, INC. |
| K063206 |
10/23/2006 |
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
| K060369 |
02/13/2006 |
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK |
DADE BEHRING, INC. |
| K060677 |
03/14/2006 |
N LATEX CDT |
DADE BEHRING, INC. |
| K061338 |
05/15/2006 |
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY |
DADE BEHRING, INC. |
| K071603 |
06/12/2007 |
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) |
DADE BEHRING, INC. |
| K061802 |
06/27/2006 |
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH |
DADE BEHRING, INC. |
| K061825 |
06/28/2006 |
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH |
DADE BEHRING, INC. |
| K061845 |
06/29/2006 |
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
DADE BEHRING, INC. |
| K061852 |
06/30/2006 |
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
| K061990 |
07/13/2006 |
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL |
DADE BEHRING, INC. |
| K062035 |
07/19/2006 |
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL |
DADE BEHRING, INC. |
| K062055 |
07/20/2006 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
| K072965 |
10/22/2007 |
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON |
DADE BEHRING, INC. |
| K063272 |
10/30/2006 |
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
| K063322 |
11/03/2006 |
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H |
DADE BEHRING, INC. |
| K063425 |
11/13/2006 |
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH |
DADE BEHRING, INC. |
| K063610 |
12/04/2006 |
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
DADE BEHRING, INC. |
| K063608 |
12/04/2006 |
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
DADE BEHRING, INC. |
| K063655 |
12/08/2006 |
DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH |
DADE BEHRING, INC. |
| K063663 |
12/08/2006 |
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
DADE BEHRING, INC. |
| K041438 |
06/01/2004 |
ADVANCED D-DIMER ASSAY |
DADE BEHRING, INC. |
| K072435 |
08/30/2007 |
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H |
DADE BEHRING, INC. |
| K020441 |
02/11/2002 |
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY |
DADE BEHRING, INC. |
| K031512 |
05/14/2003 |
EMIT II PLUS COCAINE METABOLITE ASSAY |
DADE BEHRING, INC. |
| K051597 |
06/16/2005 |
STRATUS CS D-DIMER |
DADE BEHRING, INC. |
| K032014 |
06/30/2003 |
N LATEX IGM |
DADE BEHRING, INC. |
| K041878 |
07/12/2004 |
N LATEX CYSTATIN |
DADE BEHRING, INC. |
| K032237 |
07/21/2003 |
N/T PROTEIN CONTROL |
DADE BEHRING, INC. |
| K042735 |
10/01/2004 |
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) |
DADE BEHRING, INC. |
| K052788 |
10/03/2005 |
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H |
DADE BEHRING, INC. |
| K053074 |
11/01/2005 |
N ANTISERA TO HUMAN CERULOPLASMIN |
DADE BEHRING, INC. |
| K053073 |
11/01/2005 |
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN |
DADE BEHRING, INC. |
| K053072 |
11/01/2005 |
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN |
DADE BEHRING, INC. |
| K053075 |
11/01/2005 |
N ANTISERA TO HUMAN TRANSFERRIN |
DADE BEHRING, INC. |
| K063351 |
11/06/2006 |
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH |
DADE BEHRING, INC. |
| K024038 |
12/06/2002 |
N LATEX IGA |
DADE BEHRING, INC. |
| K033908 |
12/17/2003 |
N HIGH SENSITIVITY CRP |
DADE BEHRING, INC. |
| K003696 |
11/30/2000 |
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD |
DADE BEHRING, INC. |
| K062773 |
09/18/2006 |
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN |
DADE BEHRING, INC. |
| K062923 |
09/28/2006 |
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) |
DADE BEHRING, INC. |
| K990825 |
03/12/1999 |
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K990824 |
03/12/1999 |
REVISED C-REACTIVE PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
| K031135 |
04/09/2003 |
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) |
DADE BEHRING, INC. |
| K023065 |
09/16/2002 |
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K060090 |
01/12/2006 |
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K070552 |
02/27/2007 |
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) |
DADE BEHRING, INC. |
| K011112 |
04/11/2001 |
CYCLOSPORINE CALIBRATOR |
DADE BEHRING, INC. |
| K061020 |
04/13/2006 |
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE |
DADE BEHRING, INC. |
| K051087 |
04/28/2005 |
DIMENSION VISTA INTEGRATED SYSTEM |
DADE BEHRING, INC. |
| K071224 |
05/02/2007 |
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR |
DADE BEHRING, INC. |
| K061238 |
05/03/2006 |
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K061251 |
05/04/2006 |
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR |
DADE BEHRING, INC. |
| K061655 |
06/13/2006 |
DIMENSION VISTA FLEX REAGENT CARTRIDGES |
DADE BEHRING, INC. |
| K061792 |
06/26/2006 |
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI |
DADE BEHRING, INC. |
| K062024 |
07/18/2006 |
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K062128 |
07/26/2006 |
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS |
DADE BEHRING, INC. |
| K062236 |
08/02/2006 |
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K062316 |
08/09/2006 |
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K032697 |
09/02/2003 |
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) |
DADE BEHRING, INC. |
| K983344 |
09/23/1998 |
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL |
DADE BEHRING, INC. |
| K053531 |
12/19/2005 |
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR |
DADE BEHRING, INC. |
| K003419 |
11/02/2000 |
RCRP FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K981709 |
05/04/1998 |
COAGULATION FACTOR V DEFICIENT PLASMA |
DADE BEHRING, INC. |
| K020142 |
01/16/2002 |
MICROSCAN SYNERGIES PLUS |
DADE BEHRING, INC. |
| K020173 |
01/17/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) |
DADE BEHRING, INC. |
| K020168 |
01/17/2002 |
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020182 |
01/18/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020185 |
01/18/2002 |
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020209 |
01/22/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
| K020248 |
01/24/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) |
DADE BEHRING, INC. |
| K020246 |
01/24/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) |
DADE BEHRING, INC. |
| K020249 |
01/24/2002 |
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) |
DADE BEHRING, INC. |
| K020319 |
01/30/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) |
DADE BEHRING, INC. |
| K020328 |
01/31/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) |
DADE BEHRING, INC. |
| K020398 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
| K020397 |
02/06/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) |
DADE BEHRING, INC. |
| K020413 |
02/07/2002 |
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) |
DADE BEHRING, INC. |
| K020410 |
02/07/2002 |
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) |
DADE BEHRING, INC. |
| K061536 |
06/02/2006 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K061687 |
06/15/2006 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K061872 |
07/03/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
| K062276 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
| K062293 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) |
DADE BEHRING, INC. |
| K062375 |
08/15/2006 |
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) |
DADE BEHRING, INC. |
| K062777 |
09/18/2006 |
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN |
DADE BEHRING, INC. |
| K063064 |
10/06/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) |
DADE BEHRING, INC. |
| K063065 |
10/06/2006 |
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) |
DADE BEHRING, INC. |
| K063101 |
10/10/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML |
DADE BEHRING, INC. |
| K062927 |
09/28/2006 |
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) |
DADE BEHRING, INC. |
| K063099 |
10/10/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) |
DADE BEHRING, INC. |
| K063299 |
11/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN |
DADE BEHRING, INC. |
| K061795 |
06/23/2006 |
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
| K060548 |
03/01/2006 |
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK |
DADE BEHRING, INC. |
| K071597 |
06/12/2007 |
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 |
DADE BEHRING, INC. |
| K051650 |
06/21/2005 |
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. |
DADE BEHRING, INC. |
| K071767 |
06/29/2007 |
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A |
DADE BEHRING, INC. |
| K062924 |
09/28/2006 |
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK |
DADE BEHRING, INC. |
| K073072 |
10/31/2007 |
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B |
DADE BEHRING, INC. |
| K063356 |
11/07/2006 |
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK |
DADE BEHRING, INC. |
| K063754 |
12/19/2006 |
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 |
DADE BEHRING, INC. |
| K982210 |
06/23/1998 |
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA |
DADE BEHRING, INC. |
| K002551 |
08/17/2000 |
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL |
DADE BEHRING, INC. |
| K002974 |
08/17/2000 |
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL |
DADE BEHRING, INC. |
| K010494 |
02/20/2001 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
| K060489 |
02/24/2006 |
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS |
DADE BEHRING, INC. |
| K000649 |
02/28/2000 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
| K031004 |
03/31/2003 |
SYVA EMIT II PLUS AMPHETAMINES ASSAY |
DADE BEHRING, INC. |
| K001145 |
04/10/2000 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
DADE BEHRING, INC. |
| K011235 |
04/23/2001 |
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 |
DADE BEHRING, INC. |
| K981711 |
04/27/1998 |
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 |
DADE BEHRING, INC. |
| K031377 |
05/01/2003 |
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 |
DADE BEHRING, INC. |
| K001645 |
05/30/2000 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
| K002080 |
07/10/2000 |
BEHRING COAGULATION SYSTEM, MODEL BCS |
DADE BEHRING, INC. |
| K992423 |
07/21/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
DADE BEHRING, INC. |
| K992763 |
08/17/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
DADE BEHRING, INC. |
| K072304 |
08/17/2007 |
FIBRINOGEN CALIBRATOR KIT |
DADE BEHRING, INC. |
| K042333 |
08/30/2004 |
CONTROL PLASMA N, PROC CONTROL PLASMA |
DADE BEHRING, INC. |
| K002731 |
09/01/2000 |
N LATEX B2-MICROGLOBULIN |
DADE BEHRING, INC. |
| K002885 |
09/15/2000 |
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP |
DADE BEHRING, INC. |
| K013155 |
09/21/2001 |
DADE THROMBOPLASTIN C PLUS |
DADE BEHRING, INC. |
| K993299 |
10/01/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
| K042941 |
10/25/2004 |
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS |
DADE BEHRING, INC. |
| K093848 |
12/16/2009 |
PT-MULTI-CALIBRATOR, MODEL OPAT07 |
DADE BEHRING, INC. |
| K992321 |
07/12/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
DADE BEHRING, INC. |
| K020979 |
03/26/2002 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 |
DADE BEHRING, INC. |
| K000973 |
03/27/2000 |
BEHRING COAGULATION SYSTEM (BCS) |
DADE BEHRING, INC. |
| K001064 |
04/03/2000 |
BEHRING COAGULATION TIMER ANALYZER (BCT) |
DADE BEHRING, INC. |
| K001067 |
04/03/2000 |
DADE BEHRING COAGULATION ANALYZER (BCT) |
DADE BEHRING, INC. |
| K991177 |
04/07/1999 |
OPUS TROPONIN I (CTN) TEST MODULES |
DADE BEHRING, INC. |
| K991176 |
04/07/1999 |
OPUS TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K991385 |
04/21/1999 |
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY |
DADE BEHRING, INC. |
| K991704 |
05/19/1999 |
N/T PROTEIN CONTROL LC |
DADE BEHRING, INC. |
| K991705 |
05/19/1999 |
N PROTEIN STANDARD UY |
DADE BEHRING, INC. |
| K991787 |
05/25/1999 |
N LATEX IGE MONO REAGENT |
DADE BEHRING, INC. |
| K001647 |
05/30/2000 |
BN PROSPEC SYSTEM |
DADE BEHRING, INC. |
| K011665 |
05/30/2001 |
BCT SYSTEM |
DADE BEHRING, INC. |
| K982292 |
06/30/1998 |
PREALBUMIN CALIBRATOR |
DADE BEHRING, INC. |
| K012468 |
08/02/2001 |
MODIFICATION TO N/T PROTEIN CONTROL SL |
DADE BEHRING, INC. |
| K012470 |
08/02/2001 |
MODIFICATION TO N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
| K982871 |
08/14/1998 |
DRUG CALIBRATOR II |
DADE BEHRING, INC. |
| K982880 |
08/14/1998 |
DIMENSION(R) VALPROIC (VALP) ACID METHOD |
DADE BEHRING, INC. |
| K002541 |
08/16/2000 |
PROTEIN C REAGENT |
DADE BEHRING, INC. |
| K992957 |
09/02/1999 |
ADVANCED D-DIMER |
DADE BEHRING, INC. |
| K992959 |
09/02/1999 |
BEHRING COAGULATION SYSTEM (BCS) |
DADE BEHRING, INC. |
| K002804 |
09/08/2000 |
N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
| K002852 |
09/13/2000 |
N/T PROTEIN CONTROL SL |
DADE BEHRING, INC. |
| K013114 |
09/18/2001 |
BCS SYSTEM |
DADE BEHRING, INC. |
| K013130 |
09/19/2001 |
N LP(A) CONTROL SY |
DADE BEHRING, INC. |
| K013128 |
09/19/2001 |
N LATEX LP(A) |
DADE BEHRING, INC. |
| K013126 |
09/19/2001 |
N LP(A) STANDARD SY |
DADE BEHRING, INC. |
| K993273 |
09/30/1999 |
N LATEX FERRITIN |
DADE BEHRING, INC. |
| K983693 |
10/21/1998 |
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K983722 |
10/21/1998 |
STRATUS CS TROPONIN I CALIBRATOR |
DADE BEHRING, INC. |
| K983850 |
10/30/1998 |
DIMENSION AHDL CALIBRATOR |
DADE BEHRING, INC. |
| K983849 |
10/30/1998 |
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K003501 |
11/13/2000 |
N PROTEIN STANDARD UY CALIBRATOR |
DADE BEHRING, INC. |
| K003503 |
11/13/2000 |
N LATEX CYSTATIN C |
DADE BEHRING, INC. |
| K984065 |
11/16/1998 |
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK |
DADE BEHRING, INC. |
| K984093 |
11/16/1998 |
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK |
DADE BEHRING, INC. |
| K984067 |
11/16/1998 |
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK |
DADE BEHRING, INC. |
| K984193 |
11/23/1998 |
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR |
DADE BEHRING, INC. |
| K984191 |
11/23/1998 |
MYOGLOBIN FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K003870 |
12/15/2000 |
THROMBOREL S |
DADE BEHRING, INC. |
| K994341 |
12/23/1999 |
FIBRINOGEN CALIBRATOR KIT |
DADE BEHRING, INC. |
| K993174 |
09/22/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
DADE BEHRING, INC. |
| K981622 |
05/07/1998 |
DADE TRU-LIQUID CARDIAC CONTROL |
DADE BEHRING, INC. |
| K010061 |
01/08/2001 |
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND |
DADE BEHRING, INC. |
| K010208 |
01/23/2001 |
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 |
DADE BEHRING, INC. |
| K010206 |
01/23/2001 |
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 |
DADE BEHRING, INC. |
| K020723 |
03/06/2002 |
DIMENSION ALDL CALIBRATOR, MODEL DC131 |
DADE BEHRING, INC. |
| K020724 |
03/06/2002 |
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 |
DADE BEHRING, INC. |
| K011035 |
04/05/2001 |
DIMENSION DRUG CALIBRATOR, MODEL DC22B |
DADE BEHRING, INC. |
| K011033 |
04/05/2001 |
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 |
DADE BEHRING, INC. |
| K041417 |
05/27/2004 |
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 |
DADE BEHRING, INC. |
| K032573 |
08/20/2003 |
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 |
DADE BEHRING, INC. |
| K032564 |
08/20/2003 |
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 |
DADE BEHRING, INC. |
| K032574 |
08/20/2003 |
DIMENSION DRUG CALIBRATOR II, MODEL DC49C |
DADE BEHRING, INC. |
| K022976 |
09/06/2002 |
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D |
DADE BEHRING, INC. |
| K022977 |
09/06/2002 |
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C |
DADE BEHRING, INC. |
| K033525 |
11/07/2003 |
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 |
DADE BEHRING, INC. |
| K033809 |
12/08/2003 |
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D |
DADE BEHRING, INC. |
| K994291 |
12/21/1999 |
DIMENSION SPECIAL PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
| K994293 |
12/21/1999 |
DIMENSION C4 FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K994294 |
12/21/1999 |
DIMENSION TRNF FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K994296 |
12/21/1999 |
DIMENSION C3 FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K070346 |
02/06/2007 |
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM |
DADE BEHRING, INC. |
| K060312 |
02/08/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) |
DADE BEHRING, INC. |
| K050585 |
03/07/2005 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE |
DADE BEHRING, INC. |
| K070860 |
03/28/2007 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN |
DADE BEHRING, INC. |
| K071076 |
04/16/2007 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K041150 |
05/03/2004 |
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K071268 |
05/07/2007 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE |
DADE BEHRING, INC. |
| K071316 |
05/10/2007 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN |
DADE BEHRING, INC. |
| K071317 |
05/10/2007 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN |
DADE BEHRING, INC. |
| K051311 |
05/19/2005 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN |
DADE BEHRING, INC. |
| K031602 |
05/21/2003 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) |
DADE BEHRING, INC. |
| K031601 |
05/21/2003 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) |
DADE BEHRING, INC. |
| K051478 |
06/03/2005 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN |
DADE BEHRING, INC. |
| K052346 |
08/29/2005 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K062705 |
09/11/2006 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID |
DADE BEHRING, INC. |
| K062938 |
09/28/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML |
DADE BEHRING, INC. |
| K033482 |
11/04/2003 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
| K063365 |
11/07/2006 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE |
DADE BEHRING, INC. |
| K063366 |
11/07/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE |
DADE BEHRING, INC. |
| K063564 |
11/28/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) |
DADE BEHRING, INC. |
| K053504 |
12/16/2005 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) |
DADE BEHRING, INC. |
| K060088 |
01/12/2006 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN |
DADE BEHRING, INC. |
| K051350 |
05/24/2005 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
| K994114 |
12/06/1999 |
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR |
DADE BEHRING, INC. |
| K994115 |
12/06/1999 |
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K062179 |
07/31/2006 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) |
DADE BEHRING, INC. |
| K062290 |
08/07/2006 |
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) |
DADE BEHRING, INC. |
| K062585 |
09/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN |
DADE BEHRING, INC. |
| K062596 |
09/01/2006 |
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID |
DADE BEHRING, INC. |
| K063053 |
10/04/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) |
DADE BEHRING, INC. |
| K063102 |
10/10/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) |
DADE BEHRING, INC. |
| K043546 |
12/23/2004 |
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE |
DADE BEHRING, INC. |
| K060371 |
02/13/2006 |
THE EMIT 2000 TACROLIMUS CALIBRATORS |
DADE BEHRING, INC. |
| K070853 |
03/28/2007 |
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 |
DADE BEHRING, INC. |
| K061218 |
05/01/2006 |
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 |
DADE BEHRING, INC. |
| K061390 |
05/18/2006 |
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 |
DADE BEHRING, INC. |
| K061703 |
06/16/2006 |
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) |
DADE BEHRING, INC. |
| K061702 |
06/16/2006 |
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) |
DADE BEHRING, INC. |
| K061751 |
06/21/2006 |
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 |
DADE BEHRING, INC. |
| K061750 |
06/21/2006 |
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 |
DADE BEHRING, INC. |
| K061818 |
06/28/2006 |
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) |
DADE BEHRING, INC. |
| K061838 |
06/29/2006 |
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 |
DADE BEHRING, INC. |
| K061885 |
07/03/2006 |
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 |
DADE BEHRING, INC. |
| K071811 |
07/03/2007 |
ETOH FLEX REAGENT CARTRIDGE (DF22) |
DADE BEHRING, INC. |
| K061923 |
07/07/2006 |
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) |
DADE BEHRING, INC. |
| K062034 |
07/19/2006 |
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) |
DADE BEHRING, INC. |
| K062122 |
07/25/2006 |
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) |
DADE BEHRING, INC. |
| K062121 |
07/25/2006 |
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) |
DADE BEHRING, INC. |
| K062152 |
07/27/2006 |
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 |
DADE BEHRING, INC. |
| K062162 |
07/28/2006 |
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) |
DADE BEHRING, INC. |
| K062182 |
07/31/2006 |
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 |
DADE BEHRING, INC. |
| K062191 |
07/31/2006 |
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 |
DADE BEHRING, INC. |
| K062199 |
08/01/2006 |
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) |
DADE BEHRING, INC. |
| K062334 |
08/10/2006 |
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 |
DADE BEHRING, INC. |
| K073055 |
10/30/2007 |
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 |
DADE BEHRING, INC. |
| K053157 |
11/14/2005 |
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A |
DADE BEHRING, INC. |
| K060385 |
02/14/2006 |
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT |
DADE BEHRING, INC. |
| K060503 |
02/24/2006 |
DIMENSION TACR CALIBRATOR, MODEL DC107 |
DADE BEHRING, INC. |
| K060502 |
02/24/2006 |
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 |
DADE BEHRING, INC. |
| K042407 |
09/03/2004 |
EMIT CAFFEINE ASSAY |
DADE BEHRING, INC. |
| K053061 |
10/31/2005 |
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
DADE BEHRING, INC. |
| K043028 |
11/03/2004 |
EMIT II PLUS ECSTASY ASSAY |
DADE BEHRING, INC. |
| K053108 |
11/04/2005 |
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 |
DADE BEHRING, INC. |
| K053337 |
12/01/2005 |
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 |
DADE BEHRING, INC. |
| K073604 |
12/21/2007 |
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD |
DADE BEHRING, INC. |
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